To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03130829|
Recruitment Status : Not yet recruiting
First Posted : April 27, 2017
Last Update Posted : April 28, 2017
To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC).
To assess the progression-free survival (PFS) and objective response rate (ORR) of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with NSCLC.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Stage IV NSCLC, Stage III||Dietary Supplement: Oligo Fucoidan Dietary Supplement: Placebo||Not Applicable|
This is a pilot, randomized, double-blind, multicenter study to evaluate the QoL score of Oligo Fucoidan plus platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in subjects with NSCLC. Subjects will be randomized in a 1:1 ratio to receive 4.4 g BID of Oligo Fucoidan or placebo BID. Subject randomization will be stratified by NSCLC disease stage (stage III and stage IV) and platinum-based drug (cisplatin and carboplatin).
This is a two-part study. The study treatment will be planned as follow:
- Part I (Platinum-based Treatment Phase): Oligo Fucoidan/placebo in combination with 4~6 cycles of platinum-based chemotherapy;
- Part II (Extension Phase): Continuous Oligo Fucoidan/placebo treatment after subject completed platinum-based chemotherapy.
The total study treatment duration of investigational product from Part I to Part II will be 6 months.
Dosing of oral Oligo Fucoidan/placebo will begin on Study Day -2, 2 days prior to the start of the platinum-based chemotherapy regimen, and will continue twice a day (BID) through the following 6-months treatment period, which includes platinum-based treatment phase and extension phase, if there's no treatment interruption. All subjects will receive platinum-based IV infusion starting on Day 1 of each cycle, 3 weeks per cycle. Subjects will continue to receive Oligo Fucoidan/placebo for 6 months until develop of treatment toxicity which in the Investigator's opinion prohibits for further therapy, or until radiographic progression of disease. Subjects who experience toxicities due to chemotherapy may require a delay in the dosing schedule or a dose modification. Should a subject not receive platinum-based chemotherapy on a scheduled cycle, a rescheduled cycle will be designated when chemotherapy is reintroduced, but no more than 2 weeks delay.
The visit for subjects who have completed platinum-based treatment phase will be considered as the End of Part I Visit (end of platinum-based treatment phase). The visit for subjects who have completed 6-months treatment period (Part I & Part II) will be considered as the End of Treatment (EOT) Visit. It is preferable that EOT Visit procedures will be conducted for subjects prior to the initiation of another anticancer therapy.
Radiographic tumor assessments will be conducted at screening period, Cycle 4, End of Platinum-based Treatment Phase, and EOT. Radiographic information will be collected according to the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Toxicities will be graded at each study visit according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Quality of life assessment as measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) as well as health-related quality of life questionnaire designed by the National Health Research Institutes (NHRI), NHRI QLQ-TCM, based on traditional Chinese medicine (TCM) perspective. Both of them will be performed at Study Day -2, Day 8 of Cycle 1, Day 1 of Cycle 3 & Cycle 5, and End of Platinum-based Treatment Phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, multicenter study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel, Pilot Study to Evaluate the Quality of Life Improvement of Oral Oligo Fucoidan as an Adjuvant in Subjects Receiving Platinum-based Chemotherapy With NSCLC|
|Estimated Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: Oligo Fucoidan
Oligo Fucoidan 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.
Dietary Supplement: Oligo Fucoidan
Oral, twice daily
Placebo Comparator: Placebo
Placebo 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.
Dietary Supplement: Placebo
Oral, twice daily
- Quality of Life (QoL) [ Time Frame: Day -2 to complete of Platinum-based Treatment Phase(week18) ]Comparison of the QoL score changes from Study Day -2 to End of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire
- Quality of Life (QoL) [ Time Frame: tinumDay -2 to C1D8(week1), Cycle 3(week9), and Cycle 5(week15) of Platinum-based Treatment Phase ]Comparison of the QoL score changes from Study Day -2 to C1D8, C3D1, and C5D1 of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire.
- Progression-Free Survival (PFS) [ Time Frame: Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required ]Progression-Free Survival will be evaluated according to radiographic progression per RECIST version 1.1 and survival information (death)
- Objective Response Rate (ORR) [ Time Frame: Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required ]Objective Response Rate will be evaluated using measurements according to RECIST version 1.1
- Change of Cytokines [ Time Frame: Screening (baseline), Cycle 3 (week 9), and complete of Platinum-based Treatment Phase(week18) ]To evaluate the changes of cytokine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130829
|Contact: Candy Tsai||+886 2 26980063 ext email@example.com|
|Shuang Ho Hospital||Not yet recruiting|
|New Taipei City, Taiwan, 235|
|Contact: Kang-Yun Lee, MD +886 2 22490088|
|Principal Investigator: Kang-Yun Lee, MD|
|Wan-Fang Hospital||Not yet recruiting|
|Taipei, Taiwan, 116|
|Contact: Gi-Ming Lai, MD +886 2 29307930|
|Principal Investigator: Gi-Ming Lai, MD|
|Taipei Medical University Hospital||Not yet recruiting|
|Contact: Her-Shyong Shiah, MD +886 27372181|
|Principal Investigator: Her-Shyong Shiah, MD|